A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors

Non-small Cell Lung Cancer Clinical Trial

— RADIANT  

Official title:

A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva® (Erlotinib) Following Complete Tumor Resection With or Without Adjuvant Chemotherapy in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma Who Have EGFR-positive Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373425
• Other study ID #: OSI-774-302
• Secondary ID: 2005-001747-29
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2006
• Last updated: September 1, 2015
• Start date: September 2006
• Est. completion date: June 2014

Study information

• Verified date: September 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustria: Federal Office for Safety in Health CareAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaCzech Republic: State Institute for Drug ControlFrance: Agence Nationale de Sécurité du Médicament et des produits de santéGermany: Federal Institute for Drugs and Medical DevicesGreece: National Organization of MedicinesHungary: National Institute of PharmacyItaly: The Italian Medicines AgencyKorea: Food and Drug AdministrationPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines AgencyRussia: FSI Scientific Center of Expertise of Medical ApplicationSpain: Agencia Española de Medicamentos y Productos SanitariosTaiwan: Center for Drug EvaluationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar pill following complete surgical removal of the tumor with or without chemotherapy after surgery in Stage IB-IIIA NSCLC patients.

Description:

After the initiation of the study, the sponsor became aware of an error in the drug dispensing module of the interactive voice response such that most patients who were randomized prior to 07 November 2007 were dispensed the incorrect study drug at least once. Since the integrity of the data from these patients was seriously compromised, these patients were considered unevaluable for the protocol-specified analyses. These participants are referred to as the breached protocol cohort (BPC) and those still on study treatment at the time of the breach were offered the option of receiving open-label erlotinib for up to 2 years (including posttreatment and long-term follow-up assessments), not receiving open-label erlotinib but remaining in the study for posttreatment and long-term follow-up assessment, or withdrawing consent from treatment and further assessments. Participants who had discontinued study treatment prior to the breach were not offered open-label erlotinib and remained in long-term follow-up. Data from the BPC participants were analyzed separately and were not included in the assessments of primary or secondary endpoints in the randomized cohort and were not considered part of the primary analyses.The sample size for the randomized cohort was not changed due to the BPC and the data from RC and BPC were analyzed separately.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1252
• Est. completion date: June 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary tissue from patient's surgery must be epidermal growth factor receptor (EGFR)-positive by certain tests

• Patients may have up to 4 cycles of chemotherapy after surgery

• Complete removal of the tumor by surgery

• Able to start drug under the following timelines:

• 6 months from the day of surgery for patients who get chemotherapy

• 3 months from the day of surgery for those who do not get chemotherapy

• Confirmed diagnosis of Stage IB-IIIA NSCLC

• Patients must be accessible for follow-up visits

Exclusion Criteria:

• History of prior radiotherapy for NSCLC either before or after surgery

• History of heart disease or uncontrolled heart arrhythmias within the previous year

• History of poorly controlled gastrointestinal (GI) disorders that could affect the absorption of study drug

• History of other cancer except certain skin or cervical cancers, patients who have had other cancer are eligible if they have remained disease free for at least 5 years

• Patients who have received chemotherapy for NSCLC before surgery

• Tumors with mixed histology of NSCLC and Small Cell Lung Cancer (SCLC). Patients with carcinoid tumors are not eligible.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Erlotinib
150 mg tablet
• Placebo
Placebo tablet

Locations

Country	Name	City	State
Argentina	Hospital de Rehabilitación Respiratoria María Ferrer	Buenos Aires
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Argentina	COIR	Mendoza
Argentina	Hospital Espanol de Rosario	Rosario, Santa Fe
Argentina	ISIS Centro Especializado De Luce S.A.	Santa Fé
Australia	Respiratory Clinical Trials Pty., Ltd	Adelaide
Australia	Ashford Cancer Centre	Ashford
Australia	Campbelltown Hospital	Campbelltown	New South Wales
Australia	Monash Medical Centre	East Bentleigh	Victoria
Australia	St Vincent`s Hospital Melbourne	Fitzroy	Victoria
Australia	Austin Hospital	Heidelberg	Victoria
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Royal North Shore Hospital	St Leonards	New South Wales
Austria	Universitaetsklinikum Innsbruck	Innsbruck
Austria	Allgemeines Krankenhaus der Stadt Linz	Linz
Austria	Landeskrankenhaus SalzburgUniversitaetsklinikum der PMUUniversitaetsklinik für Pneumologie	Salzburg
Austria	AKH Wien	Wien
Austria	Krankenhaus Hietzing	Wien
Austria	SMZ Baumgartner Hoehe - Otto Wagner Spital	Wien
Austria	SMZ Baumgartner Höhe - Otto- Wagner-Spital	Wien
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	Hôpital Erasme	Brussels
Belgium	Le Grand Hôpital de Charleroi	Charleroi
Belgium	Centre Hospitalier Jolimont-Lobbes	La Louvière
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Cancer Center of Southeastern Ontario at Kingston General Hospital	Kingston	Ontario
Canada	Trillium Health Partners - Credit Valley Hospital	Mississauga	Ontario
Canada	McGill Dept. of Oncology	Montreal	Quebec
Canada	Montreal General Hospital	Montreal	Quebec
Canada	Royal Victoria Hospital	Montreal	Quebec
Canada	Stronach Regional cancer Centre at Southlake	Newmarket	Ontario
Canada	RS MacLaughlin Durham Regional Cancer Centre	Oshawa	Ontario
Canada	Sault Area Hospital	Sault Ste Marie	Ontario
Canada	Thunder Bay Regional Health Science Centre	Thunder Bay	Ontario
Canada	St. Joseph's Health Centre	Toronto
Canada	Toronto General Hospital	Toronto	Ontario
Czech Republic	Nemocnice Ceske Budejovice, a.s.	Ceske Budejovice
Czech Republic	Fakultni nemocnice OstravaKlinika tuberkulozy a respiracnich nemoci	Ostrava-Poruba
Czech Republic	FN Bulovka Klinika plincni a hrrudni chirurgie	Praha
France	Centre d`Oncologie et de Radiothérapie du Pays Basque	Bayonne
France	C.H.U. Morvan, Institut de Cancerologie et d`Hématologie	Brest cedex
France	CHU de Caen - Service de pneumologie	Caen Cedex
France	CHU Clermont Ferrand - Hôpital Gabriel Montpied - Service de pneumologie	Clermont-Ferrand cedex 1
France	Hopital De La Croix-Rousse Service de Pneumologie	Lyon cedex 04
France	Institut Paoli-Calmettes	Marseille cedex 9
France	Hôpital de Tenon	Paris
France	Fondation Hôpital Saint Joseph	PARIS cedex 14
France	Centre Catalan d'Oncologie	Perpignan
France	CHU - Hopital Pontchaillou - Service de pneumologie	Rennes cedex 9
France	Institut de Cancérologie de la Loire	Saint Priest en Jarez
France	CHU Larrey Service de Pneumologie, Clinique des voies respiratoires	Toulouse	Cedex 9
France	Hôpital de Brabois	Vandoeuvre-lès-Nancy Cedex
Germany	Zentralklinik Bad Berka	Bad Berka
Germany	HELIOS Klinikum Emil von Behring GmbH	Berlin
Germany	Augusta-Krankenanstalt Bochum	Bochum
Germany	Fachkrankenhaus Coswig	Coswig
Germany	Universitaetsklinikum Essen	Essen
Germany	Krankenhaus Nordwest	Frankfurt/Main
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Universitätsklinikum Göttingen	Göttingen
Germany	Lungenclinic Großhansdorf	Großhansdorf
Germany	Städtisches Krankenhaus Martha-Maria, Halle-Dölau	Halle (Saale)
Germany	Asklepios Klinik Harburg	Hamburg
Germany	Thoraxklinik Heidelberg	Heidelberg
Germany	Lungenklink Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH	Hemer
Germany	St. Vincentius-Kliniken Karlsruhe	Karlsruhe
Germany	Universitaetsklinikum Schleswig-Holstein	Lübeck
Germany	Universitätsklinikum Mainz	Mainz
Germany	Asklepios Klinikum Gauting	Muenchen-Gauting
Germany	Pius Hospital Oldenburg	Oldenburg
Germany	Schwarzwald-Baar Klinikum	Villingen-Schwenningen
Greece	IASO GENERAL Hospital of Athens	Athens
Greece	"G. Papanikolaou" General Hospital of Thessaloniki	Thessaloniki
Greece	"Papageorgiou" General Hospital of Thessaloniki	Thessaloniki
Hungary	Országos Korányi TBC és Pulmonológiai Intézet	Budapest
Hungary	Semmelweis Egyetem Altalanos Orvostudomanyi Kar Pulmonologiai Klinika	Budapest
Hungary	Csongrad Megyei Onkormanyzat, Mellkasi Betegsegek Szakkorhaza	Deszk
Hungary	Pecsi Tudomany Egyete m Klinikai Kozpont, I.sz Belgyogyaszati Klinika Pulmonologiai Munkacsoport	Pécs
Hungary	Fejer Megyei Szent Gyorgy Korhaz	Szekesfehervar
Hungary	Vas Megyei Markusovszky Lajos Altalanos Rehabilitacios es Gyogyfurdo Korhaz, Egyetemi Oktatoko Zarkoruen Mukodo Nonprofit Reszveny Tarsasag	Szombathely
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I	Ancona
Italy	Ospedale Bellaria	Bologna
Italy	Ospedale Garibaldi Nesima	Catania
Italy	Istituto Nazionale per la Ricerca e la Cura del Cancro	Genova
Italy	Azienda Ospedaliero- Universitaria di Parma	Parma
Italy	Ospedale S. Maria della Misericordia	Perugia
Italy	Azienda Ospedaliera San Camillo Forlanini	Roma
Korea, Republic of	Saint Vincent's Hospital	Gyeonggi-Do
Korea, Republic of	Gachon Medical School Ghil Medical Center	Incheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei Univ. College of Medicine	Seoul
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 4	Lublin
Poland	Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy	Otwock
Poland	Wielkoposkie Centrum Pulmonologii i Torakochirurgii, Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii	Poznan
Poland	Specjalistyczny Szpital im. prof.Alfreda Sokolowskiego	Szczecin
Poland	Centrum Onkologii - Instytut im. Marii Skllodowskiej - Curie	Warsaw
Poland	Dolnoslaskie Centrum Chorob Pluc we Wroclawiu, Katedra i Klinika Pulmonologii i Nowotworow Pluc Akademii Medycznej	Wroclaw
Romania	Institutul Oncologic Al. Trestioreanu	Bucuresti
Romania	Institutul Oncologic Al. Trestioreanu Sectia Oncologie Medicala II	Bucuresti
Romania	Institutul Oncologic Prof. Dr. Ion Chiricuta	Cluj-Napoca
Romania	Oncoloab SRL	Craiova	Dolj
Romania	Centrul de Oncologie Medicala	Iasi
Romania	Spitalui Clinic Judetean de Urgenta, Sectia de Oncologie	Oradea	Bihor
Romania	Spitalul Clinic Judetean Sibiu	Sibiu
Russian Federation	State Healthcare Institution "Arkhangelsk Regional Clinical Oncology Dispensary"	Arkhangelsk
Russian Federation	State Healthcare Institution "Regional Clinical Oncology Dispensary"	Kemerovo
Russian Federation	State Healthcare Institution "Region Clinical Hospital # 1 n.a. professor S.V. Ochapovsky"	Krasnodar
Russian Federation	Institution of the RAMS "Russian Oncology Scientific Centre n.a. N.N. Blokhin under the Russian Academy of Medical Sciences"	Moscow
Russian Federation	State Institution "Central Military Clinical Hospital n.a. academician N.N. Burdenko under the Ministry of Defense of Russia"	Moscow
Russian Federation	Federal State Institution "Petrov Scientific Research Institute of Oncology of Rosmedtechnology"	Saint-Petersburg
Russian Federation	Saint-Petersburg State Healthcare Institution "City Clinical Oncology Dispensary"	Saint-Petersburg
Russian Federation	State Educational Institution of Higher Professional Education "Saint-Petersburg State Medical University n.a. ac. I.P. Pavlov of the Ministry of Healthcare and Social Development of the Russian Federation"	Saint-Petersburg
Russian Federation	Regional State Budget Healthcare Instiution"Tomsk Regional Oncology Dispensary"	Tomsk
Russian Federation	State Healthcare Institution of Yaroslavl Region "Regional Clinical Oncology Hospital"	Yaroslavl
Spain	ICO (Institut Catalá d´Oncología)	L` Hospitalet de Llobregat	Barcelona
Spain	Hospital Oncologico MD Anderson	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Puerta de Hierro Majadahonda	Majadahonda	Madrid
Spain	Hospital Carlos Haya	Málaga
Spain	Hospital Clínico Virgen de la Victoria	Málaga
Spain	Fundació Althaia	Manresa	Barcelona
Spain	Clinica Universitaria de Navarra	Pamplona
Spain	Corporació Sanitaria Parc Taulí	Sabadell	Barcelona
Spain	Hospital Universitario Marques de Valdecilla	Santander
Spain	Hospital Universitario de Valme	Sevilla
Spain	Hospital Virgen de la Salud de Toledo	Toledo
Spain	Hospital General Universitario de Valencia	Valencia
Taiwan	Changhua Christian Hospital	Changhua
Taiwan	Chang Gung Medical Foundation	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital	Taoyuan
United Kingdom	Birmingham Heartlands Hospital	Birmingham
United Kingdom	Bristol Haematology and Oncology Centre	Bristol
United Kingdom	Ninewells Hospital	Dundee
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow
United Kingdom	The Royal Surrey County Hospital NHS Trust	Guildford
United Kingdom	Leicester Royal Infirmary	Lecester
United Kingdom	St James' Institute of Oncology, Bexley Wing, St James' University Hospital	Leeds
United Kingdom	Guy`s Hospital	London
United Kingdom	Royal Marsden Hospital	London
United Kingdom	Royal Marsden Hospital	Sutton
United States	University of New Mexico Health Science Center	Albuquerque	New Mexico
United States	Texas Oncology, P.A. - Amarillo	Amarillo	Texas
United States	St. Joseph Mercy Hospital	Ann Arbor	Michigan
United States	Peachtree Hematology-Oncology Consultants, P.C.	Atlanta	Georgia
United States	Rocky Mountain Cancer Center- Aurora	Aurora	Colorado
United States	University of Colorado Hospital	Aurora	Colorado
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	Texas Oncology Beaumont	Beaumont	Texas
United States	Cancer Care Associates - Medical Oncology	Bethlehem	Pennsylvania
United States	Tower Cancer Research Foundation	Beverly Hills	California
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Mountain States Tumor Institute	Boise	Idaho
United States	Caritas St. Elizabeth's Medical Center	Boston	Massachusetts
United States	Rocky Mountain Cancer Centers-Boulder	Boulder	Colorado
United States	Cancer Care of Maine	Brewer	Maine
United States	Interlakes Oncology Hematology, PC	Brockport	New York
United States	Montefiore Medical Center	Bronx	New York
United States	Minnesota Oncology Hematology, P.A.	Burnsville	Minnesota
United States	Interlakes Oncology Hematology, PC	Canadaigua	New York
United States	Aultman Hospital/ North Canton Medical Foundation	Canton	Ohio
United States	Indiana University Health	Carmel	Indiana
United States	Raleigh Hematology Oncology Associates d/b/a Cancer Center of North Carolina	Cary	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago, Section of Hematology/Oncology	Chicago	Illinois
United States	Onc and Hem Associates of SW VA, Inc.	Christiansburg	Virginia
United States	Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care	Christiansburg	Virginia
United States	University Hopsitals of Cleveland	Cleveland	Ohio
United States	Penrose St. Francis Health Services	Colorado Springs	Colorado
United States	Rocky Mountain Cancer Center	Colorado Springs	Colorado
United States	Rocky Mountain Cancer Center	Colorado Springs	Colorado
United States	Missouri Cancer Associates	Columbia	Missouri
United States	South Carolina Oncology Assoc., PA	Columbia	South Carolina
United States	Hematology Oncology Consultants Inc.	Columbus	Ohio
United States	NH Oncology-Hematology PA (Co)	Concord	New Hampshire
United States	Cookeville Regional Medical Center	Cookeville	Tennessee
United States	Baylor Charles A Sammons Cancer Center	Dallas	Texas
United States	Texas Oncology Texas Cancer Center at Medical City	Dallas	Texas
United States	Rocky Mountain Cancer Center-Midtown	Denver	Colorado
United States	Rocky Mountain Cancer Centers- Rose	Denver	Colorado
United States	City of Hope Nat`l Medical Center	Duarte	California
United States	Cancer Centers of the Carolinas	Easley	South Carolina
United States	Minnesota Oncology Hematology, P.A.	Edina	Minnesota
United States	Indiana University Health	Fishers	Indiana
United States	Texas Oncology - Flower Mound	Flower Mound	Texas
United States	Texas Oncology Southwest Forth Worth	Fort Worth	Texas
United States	Texas Oncology, Fort Worth	Ft. Worth	Texas
United States	Texas Oncology, Garland	Garland	Texas
United States	Interlakes Oncology Hematology, PC	Geneva	New York
United States	Bostin Baskin Cancer Foundation	Germantown	Tennessee
United States	St. Francis Cancer Treatment Center	Grand Island	Nebraska
United States	Indiana University Health	Greenfield	Indiana
United States	Cancer Centers of the Carolinas	Greenville	South Carolina
United States	Cancer Centers of the Carolinas	Greenville	South Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Virginia Oncology Associates	Hampton	Virginia
United States	Comprehensive Cancer Centers of Nevada	Henderson	Nevada
United States	Carolina Oncology Specialists PA	Hickory	North Carolina
United States	NH Oncology-Hematology PA	Hooksett	New Hampshire
United States	Leonard J. Chabert Medical Center	Houma	Louisiana
United States	Florida Cancer Institute-New Hope	Hudson	Florida
United States	Indiana University Health	Indianapolis	Indiana
United States	Indiana University Health	Indianapolis	Indiana
United States	Cancer Specialists of North Florida	Jacksonville	Florida
United States	Cancer Specialists of North Florida	Jacksonville	Florida
United States	Joliet Oncology Hematology Assoc., LTD	Joliet	Illinois
United States	Tennessee Cancer Specialists	Knoxville	Tennessee
United States	Watson Clinic LLP	Lakeland	Florida
United States	Rocky Mountain Cancer Centers	Lakewood	Colorado
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Arkansas for Medical Science	Little Rock	Arkansas
United States	Rocky Mountain Cancer Centers-Littleton	Littleton	Colorado
United States	Loma Linda University Medical Center	Loma Linda	California
United States	Rocky Mountain Cancer Center-Sky Ridge	Lone Tree	Colorado
United States	Rocky Mountain Cancer Centers-Longmont	Longmont	Colorado
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	USC/ Norris Comprehensive Cancer Center	Los Angeles	California
United States	Norton Healthcare, Inc.	Louisville	Kentucky
United States	Central Georgia Cancer Care, PC	Macon	Georgia
United States	Minnesota Oncology Hematology, P.A.	Maplewood	Minnesota
United States	Northwest Georgia Oncology Centers, PC	Marietta	Georgia
United States	Loyola University Medical Center	Maywood	Illinois
United States	Bostin Baskin Cancer Foundation	Memphis	Tennessee
United States	Family Cancer Center Foundation, Inc.	Memphis	Tennessee
United States	West Clinic	Memphis	Tennessee
United States	Mountain States Tumor Institute	Meridian	Idaho
United States	Advanced Medical Specialties	Miami	Florida
United States	Minnesota Oncology Hematology, P.A.	Minneapolis	Minnesota
United States	Sarah Cannon Cancer Center	Nashville	Tennessee
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Cancer Care Centers of South Texas - HOAST	New Braunfels	Texas
United States	Yale University	New Haven	Connecticut
United States	Florida Cancer Institute- New Hope	New Port Richey	Florida
United States	Advanced Oncology Associates	New Rochelle	New York
United States	The New York Presbyterian-Weill Medical College of Cornell University	New York	New York
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Virginia Oncology Associates	Newport News	Virginia
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Nebraska Methodist Hospital	Omaha	Nebraska
United States	Florida Cancer Specialists	Orlando	Florida
United States	Comprehensive Cancer Center at Desert Regional Medical Center	Palm Springs	California
United States	Texas Oncology - Paris	Paris	Texas
United States	Rocky Mountain Cancer Center-Parker	Parker	Colorado
United States	The Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburg	Pennsylvania
United States	Texas Oncology - Plano East	Plano	Texas
United States	Bay Area Cancer Research Group, LLC	Pleasant Hill	California
United States	Hematology Oncology Associates of the Treasure Coast	Port St. Lucie	Florida
United States	Earle A Chiles Research Institute	Portland	Oregon
United States	Northwest Cancer Specialists, PC	Portland	Oregon
United States	Northwest Cancer Specialists, PC	Portland	Oregon
United States	Northwest Cancer Specialists, PC	Portland	Oregon
United States	Kootenai Cancer Center	Post Falls	Idaho
United States	Raleigh Hematology Oncology Associates	Raleigh	North Carolina
United States	Raleigh Hematology Oncology Associates	Raleigh	North Carolina
United States	Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care	Roanoke	Virginia
United States	Interlakes Oncology Hematology, PC	Rochester	New York
United States	Interlakes Oncology Hematology, PC	Rochester	New York
United States	Onc and Hem Assoc of SW VA, Inc d/b/a Blue Ridge Cancer Care	Salem	Virginia
United States	Cancer Care Centers of South Texas-HOAST	San Antonio	Texas
United States	University of California, San Francisco Comprehensive Cancer Center	San Francisco	California
United States	Christus St. Vincent Regional Cancer Center	Santa Fe	New Mexico
United States	Univ. of Washington/ Seattle Cancer Care Alliance	Seattle	Washington
United States	Cancer Centers of the Carolinas, Seneca	Seneca	South Carolina
United States	Smilow Cancer Hospital Care Center	Sharon	Connecticut
United States	City of Hope Medical Group (COHMG)	South Pasadena	California
United States	Cancer Centers of the Carolinas	Spartanburg	South Carolina
United States	Cancer Care Northwest	Spokane	Washington
United States	Cancer Care Northwest-North	Spokane	Washington
United States	Cancer Care Northwest-Valley	Spokane Valley	Washington
United States	Heartland Regional Medical Center d/b/a Heartland Clinic	St. Joseph	Missouri
United States	Minnesota Oncology Hematology	St. Paul	Minnesota
United States	Hematology Oncology, P.C.	Stamford	Connecticut
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Rocky Mountain Cancer Centers	Thornton	Colorado
United States	Smilow Cancer Hospital Care Center	Torrington	Connecticut
United States	St. Joseph Medical Center`s Cancer Institute	Towson	Maryland
United States	Northwest Cancer Specialists, PC	Tualatin	Oregon
United States	Arizona Cancer Center	Tucson	Arizona
United States	Mountain States Tumor Institute	Twin Falls	Idaho
United States	Texas Oncology -Tyler	Tyler	Texas
United States	Northwest Cancer Specialist, P.C.	Vancouver	Washington
United States	Northwest Cancer Specialists, P.C.	Vancouver	Washington
United States	Texas Oncology Cancer Care and Research Center	Waco	Texas
United States	University of Kansas Medical Center	Westwood	Kansas
United States	Minnesota Oncology Hematology, P.A.	Woodbury	Minnesota
United States	Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care	Wytheville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
OSI Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Canada,  Czech Republic,  France,  Germany,  Greece,  Hungary,  Italy,  Korea, Republic of,  Poland,  Romania,  Russian Federation,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free Survival (DFS)	DFS is the time from the date of randomization until the first day non-small cell lung cancer (NSCLC) relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date.	Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).	No
Primary	Disease Free Survival (DFS)	DFS is the time from the date of randomization until the first day that non-small cell lung cancer (NSCLC) relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date.	Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cutoff date of 11 June 2014 (maximum time on follow-up was 78 months).	No
Secondary	Overall Survival (OS)	Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.	Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).	No
Secondary	Overall Survival (OS)	Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.	Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).	No
Secondary	Disease-free Survival in Participants With EGFR Mutation - Positive Tumors	Disease-free survival (DFS) is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date. Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.	Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).	No
Secondary	Disease-free Survival in Participants With EGFR Mutation - Positive Tumors	Disease-free survival (DFS) is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date. Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.	Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).	No
Secondary	Overall Survival in Participants With EGFR Mutation - Positive Tumors	Overall survival is defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.; Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.	Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months)	No
Secondary	Overall Survival in Participants With EGFR Mutation - Positive Tumors	Overall survival is defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.; Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.	Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months)	No
Secondary	Number of Participants With Adverse Events (AEs)	An AE was defined as any untoward medical occurrence in a study participant and did not necessarily have a causal relationship with study treatment.; An AE was considered serious if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a participant, other important medical events, or is on the Astellas Always Serious List.; A drug-related AE was any AE with at least a possible relationship to study treatment as assessed by the investigator. Severity was graded by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events, v3.0, where Grade 1=Mild AE; Grade=2 Moderate AE; Grade 3=Severe AE; Grade 4=Life-threatening or disabling; Grade 5=Death related to AE. AEs leading to death include deaths that occurred more than 30 days after the last dose of study drug.	From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 11.9 months for erlotinib and 21.9 months for placebo. Data are based off the 11 June 2014 data cut-off date.	No

External Links

•   Link to results on Astellas Clinical Study Results website